Project: Regulatory Affaires Expert (Fixed or Freelancer) – Belgium

Introduction

Are you passionate about Regulatory Affairs? Do you like to plan and execute the necessary regulatory activities, with the ultimate aim of obtaining marketing authorizations globally? Then apply for this Regulatory Affairs Expert job today.

Organization

Q-People

Function

As Regulatory Affairs Expert you will be responsible for:

– Supports the Regulatory Lead in planning and executing the necessary regulatory activities
– SPOC for assigned responsibilities on the product
– Assume responsibilities for contact with 3rd party partners (mainly CROs), building strong relationships
for assigned project(s), in line with the Regulatory Lead
– Provide regulatory expertise and strategy, in alignment with the Projects
– Support and deliver quality regulatory submissions in line with the applicable regulations, directives and
guidelines, and in line with agreed strategies and timelines.
– Ensure that all documents and information are adequately captured in a timely fashion in the applicable
systems (document management, databases, etc).
– Prepare and communicate regulatory strategic and operational plans for assigned projects
– Maintain awareness of external regulatory environment, new guidelines and legislation

Requirements

Ideal Profile for the job as Regulatory Affairs Expert:

– Scientific degree (Pharmacist, bio-engineer,…)
– 5-10 years of experience in EU regulatory procedures and legislation of drug development and clinical
trial applications.
– Strong knowledge of English
– Strong project planning, analytical, communication and interpersonal skills
– Immediately available

Offer

What’s in it for you?

– Open and flat organization structure with a HR-coach that you individually follow-up and work with you
for an individual career plan
– Thanks to our Q-academy we offer you an extensive education package to learn continuously and to
strengthen your skills.
– Fixed contract with extra benefits. Besides your salary you get a (hybrid) company car, fuel card, net
allowance, insurances, meal vouchers (8€) and 13th month.

Information

Kelly Platteuw | Talent Manager
M.: +32 (0)493/07.70.65
[email protected]
Place de l’Université 16 | Louvain-la-Neuve

Application

Kelly Platteuw | Talent Manager
M.: +32 (0)493/07.70.65
[email protected]
Place de l’Université 16 | Louvain-la-Neuve

 

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